Training Program on Application of Usability Engineering to Medical Devices based on IEC 62366-1:2015

In today's day and age, medical devices are increasingly becoming complicated. IEC 62366-1:2015 defines a process through which a medical device manufacturer can analyse, specify, develop, and evaluate the usability of a medical device concerning safety. This process helps the manufacturer analyse and reduce the risks associated with everyday medical device use. This standard also enables the manufacturer to identify the risks related to the abnormal use of the device. It also helps manufacturers improve the device's usability by designing an appropriate usability engineering process.

Our experts will conduct this 2-day course, comprising tutor-led sessions, discussions, exercises, and case studies, to ensure that the delegates know and understand standard requirements and skills to implement them effectively in their organisations.

• Key parts of IEC 62366-1
• Written for easier to understand intent / implementation
• Closer ties to ISO 14971, Medical Device Risk Management
• Closer adherence to US FDA guidance; more harmonization
• Planning requirements
• Defined engineering process
• User interface considerations

• Senior Management, Middle Management, QA/RA, Operations, Production, Engineering, Marketing and Medical Device Consultants

• Understand the key parts of IEC 62366-1
• Gain insights about the standard from our experts
• Understand the terminology and compliance requirements

Participants will be assessed throughout the course for punctuality, presentation skills, their involvement in classroom exercises and finally through a written examination (open book) at the end of the course. Participants who will score 70% and above in the written examination will be issued with TÜV SÜD South Asia’s certificate. Participants who are unable to achieve the passing criteria will be issued a certificate of attendance.

1. When can I get the certificate?

Application of Usability Engineering to Medical Devices based on IEC 62366-1:2015 certification will be issued within 21 working days from the examination date.

2. When can I get the training material and invite?

One day before the commencement of the training program.

3. How do I pay the fees for training and examination?

Online mode

4. What are the benefits of the Application of Usability Engineering to Medical Devices based on IEC 62366-1:2015 Program?

• Understand the key parts of IEC 62366-1
• Gain insights about the standard from our experts
• Understand the terminology and compliance requirements

5. Is there any refund policy for the paid fees?

Please refer to Cancellation and Refund policy page.